BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® ZIRCONIA ABUTMENT

    MDR report key: 4031526 · Received August 22, 2014

    Report

    Report Number
    0001038806-2014-00108
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Report Date
    July 29, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK052648
    Removal / Correction Number
    Z-1215-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF THE DHR AND 3SHAPE, THE DESIGN IS WITHIN SPECIFICATION. NO PRODUCT WAS RETURNED FROM THE CUSTOMER. BASED ON THE INVESTIGATION RESULTS NO SPECIFIC ROOT CAUSE CAN BE DETERMINED. WHEN A FRACTURE OF A ZIRCONIA ABUTMENT IS OBSERVED ABOVE THE SEATING SURFACE OF THE ABUTMENT, THE ROOT CAUSE OF THE FRACTURE MAY RELATED TO THE DESIGN OF THE SCREW ACCESS HOLE. ALSO, IF THE FRACTURE OF A ZIRCONIA ABUTMENT IS SEEN AT OR ADJACENT TO THE MATING HEX OR BOSS, THE ROOT CAUSE IS RELATED TO THE DESIGN OF THE HEX AND BOSS CONNECTION FEATURES.

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RECEIVED FOR EVALUATION. THIS EVENT IS BEING REPORTED DUE TO A SINGLE PRECEDING MEDICAL DEVICE REPORT WHERE SURGICAL INTERVENTION DID OCCUR. THIS EVENT IS A SUBSEQUENT MALFUNCTION. THE RISK TO THE PATIENT IS REMOTE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE ZIRCONIA ABUTMENT PLACED IN THE PATIENT'S MOUTH HAD FRACTURED. THE DOCTOR REPORTED THAT THERE WAS NO SERIOUS PATIENT INJURY, NO DETERIORATION IN PATIENT¿S HEALTH AND NO CONTRIBUTING CONDITIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508986 BELLATEK® ZIRCONIA ABUTMENT BELLATEK® ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1151278

    Patients

    Seq Age Sex Outcome Treatment
    1